Identity
- Trade Name
- Night Guard Resin for 3D Printing EUDAMED
- Device Name
- Night Guard Resin for 3D Printing EUDAMED
- Model / Reference
- DN10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978646900128 EUDAMED
- Basic UDI-DI
- 697864690NGR23 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Night Guard Resin for 3D Printing by Jinhua Raychen New Material Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697864690NGR23 | Class I | Active |
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Manufacturer
- Manufacturer
- Jinhua Raychen New Material Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000047792
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED c48715e4-f950-4e9e-b537-5537597b495e 61 fields · synced Oct 8, 2026